European Journal of Heart Failure Lauds BioControl Medical’s Research
on Vagus Nerve Stimulation for Treating HF

December 11, 2012 07:00 AM Eastern Standard Time

YEHUD, Israel & NEW HOPE, Minn.--(BUSINESS WIRE)--BioControl
Medicalhas announced that the pilot clinical study of its CardioFit®
vagus nerve stimulation system has been recognized as seminal original
research in the European Journal of Heart Failure. According to a recent
editorial, “the highly cited open-label Phase II study [of the
CardioFit] by De Ferrari et al. demonstrated for the first time that
chronic vagus nerve stimulation is associated with improvements in New
York Heart Association (NYHA) class, 6 min[ute] walk test, left
ventricular ejection fraction, and systolic volumes up to 1 year,
[setting] the stage for further investigations and clinical trials in
this new era of device thearapy.”1,2

Conducted in Italy, Germany, The Netherlands and Serbia, the
multi-center pilot
clinical study of the CardioFit was designed to assess the six-month
safety and clinical response to the therapy in 32 patients with NYHA
II-IV heart failure on optimized background medical therapy. Study data
showed that patients experienced sustained significant improvement
across key clinical and self-reported quality of life measures at six
and 12 months.2 Results of the original pilot study were
published in the European
Heart Journal in April 2011.

“It is extremely gratifying to see our work not only published in the
European Heart Journal but also recognized for its impact by the
European Journal of Heart Failure,” said Dr. Goran Milasinovic, a
CardioFit pilot study investigator at the Clinical Center of Serbia in
Belgrade. “Vagus nerve stimulation has proven to be a very exciting new
area of exploration in the treatment of heart failure, with additional
clinical study of its potential benefits now well underway.”

More recent clinical research on the CardioFit includes an extension of
the pilot study that continued to follow 19 patients. Presented at the
American Heart Association Scientific Sessions 2012 in November, the
results of the extended study showed that the CardioFit’s favorable
clinical effects - as demonstrated by improved hemodynamics, quality of
life and six-minute walk test - were maintained in patients beyond the
study’s original six- and 12-month evaluation points, up to 24 months.3
Patient follow up now extends beyond four years, with good therapy
tolerance and no reported safety issues.

In addition, the safety and efficacy of the CardioFit is being explored
further in the INOVATE-HF
(INcrease Of VAgal TonE in Heart Failure) global, multi-center,
investigational device exemption (IDE) clinical study. Initiated in
April 2011, INOVATE-HF is a prospective, randomized, controlled clinical
study that will evaluate the system’s potential to reduce
hospitalization and death among patients with HF, while also exploring
whether combined treatment with CardioFit and prescription drug therapy
is more effective than drug therapy alone.4

“The INOVATE-HF study is an important pivotal trial that may ultimately
position vagus nerve stimulation as a valuable new therapeutic option
for patients with HF,” said Dr. Douglas Mann, an INOVATE-HF study
investigator at Washington University School of Medicine in St. Louis,
Mo. “We are encouraged that our colleagues in Europe have validated the
breakthrough nature of the earlier research and the need for additional
study of the CardioFit in a broader population of patients.”

About the CardioFit

The CardioFit system consists of a stimulator, a sensor lead and a
stimulation lead, which are implanted under the skin of the chest. The
sensor lead is extended from the stimulator to the right ventricle of
the heart, and the stimulation lead is extended from the stimulator to
the vagus nerve on the right side of the neck. Once activated, the
stimulator’s electrical pulses are transferred via the stimulation lead
to the vagus nerve. At the same time, the sensor lead monitors changes
in heart activity and turns stimulation on or off accordingly. Like a
pacemaker, the CardioFit System can be programmed on and off via
external wireless communication with the device.

About BioControl Medical

Headquartered in Yehud, Israel with offices in New Hope, Minn.,
BioControl Medical develops and markets advanced implantable devices for
the treatment of autonomic disorders, conditions whereby the autonomic
nervous system ceases to function properly, resulting in a disruption to
the control of involuntary body processes. The devices enable controlled
electrical stimulation of various nerves to achieve therapeutic results.
For more information on BioControl Medical, visit www.biocontrol-medical.com.

Caution: In the United States, the CardioFit is an investigational
device. Limited by Federal (or United States) law to investigational use.